Lymphedema, Lower LimbNCT07626645
Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema
A study testing Extracorporeal Shock Wave Therapy (ESWT) in people with Lymphedema, Lower Limb and Extracorporeal Shock Wave Therapy, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life. The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphedema, Lower Limb, Extracorporeal Shock Wave Therapy, Edema Leg
- What is being tested?
- Extracorporeal Shock Wave Therapy (ESWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years
- Clinical diagnosis of lower extremity lymphedema established at least 6 months prior to enrollment
- Completion of at least one cycle of CDT Phase 1 (intensive decongestive phase) within the preceding six months
- Currently in CDT Phase 2 (maintenance phase) with active use of compression garments
- Ability and willingness to provide written informed consent
Who cannot join
- Active chemotherapy or radiotherapy
- Active infection
- Lower extremity vascular diseases including deep vein thrombosis or arterial insufficiency
- Presence of a cardiac pacemaker
- Pregnancy
- Bleeding disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Hospital, Department of Physical Medicine and Rehabilitation, Ankara, 06560
Ankara, Yenimahalle, 06560
Ayca Utkan Karasu, MD, +905365759757 ext. +903122025219, ayca_utkan@yahoo.com
Turkan Gokcelik, MD, +905078492343, turkancanturk@gmail.com
About this study
Official title: Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Lower Extremity Lymphedema: A Randomized Controlled Trial
Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life. The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the maintenance phase. This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) as an adjunct to standard CDT maintenance therapy in patients with lower extremity lymphedema. Participants will be randomly allocated to either an active ESWT group or a sham ESWT group, with both groups continuing standard CDT maintenance throughout the study. ESWT will be administered twice weekly for five sessions. Changes in limb volume, skin thickness and subcutaneous tissue thickness assessed by ultrasonography, pain, functional status, and quality of life will be evaluated at baseline, after treatment, and at one-month follow-up.
Read the detailed description
Lower extremity lymphedema results from impairment of the lymphatic system and is characterized by progressive tissue fibrosis, chronic limb swelling, recurrent infections, and reduced quality of life. Complex Decongestive Therapy (CDT), recommended by the International Society of Lymphology, remains the gold-standard treatment. Despite adherence to CDT, many patients continue to experience persistent symptoms and functional decline, underscoring the need for effective adjunctive interventions.
Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive modality that has shown potential benefits in reducing fibrosis and improving lymphatic function. While its efficacy has been reported in upper extremity lymphedema, evidence in lower extremity lymphedema remains limited.
This single-center, prospective, randomized, double-blind, placebo-controlled trial will be conducted at the Department of Physical Medicine and Rehabilitation, Gazi University Faculty of Medicine. Patients currently in CDT Phase 2 (maintenance phase) will be randomly assigned in a 1:1 ratio to receive either active ESWT or sham ESWT, using stratified randomization by lymphedema stage. All participants will continue standard maintenance therapy - compression garments, skin care, and exercise - throughout the study. ESWT will be applied to fibrotic tissue regions and periinguinal and peripopliteal lymph node areas using the EMS Swiss DolorClast® device, with 3,000 impulses per session at 20 Hz and 2 bar. The primary outcome is change in lower extremity circumferential measurements and limb volume. Secondary outcomes include skin and subcutaneous tissue thickness assessed by ultrasonography, pain intensity measured by the Visual Analogue Scale (VAS), lymphedema-specific quality of life evaluated by the LYMQOL-Leg, and functional status assessed by the Lower Extremity Functional Scale (LEFS). All outcomes will be assessed at baseline, immediately after treatment, and at one-month follow-up.
- Conditions
- Lymphedema, Lower Limb, Extracorporeal Shock Wave Therapy, Edema Leg, Sham-controlled, Placebo Control Design
- Being tested
- Extracorporeal Shock Wave Therapy (ESWT), Sham Extracorporeal Shock Wave Therapy (Sham ESWT)
- Keywords
- Lower Extremity Lymphedema, Extracorporeal Shock Wave Therapy (ESWT), Complex Decongestive Therapy (CDT), Limb Volume, Ultrasonography, skin and subcutaneous tissue thickness, Quality of Life
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave Therapy (ESWT)Device
Also called Extracorporeal Shock Wave Therapy, ESWT
Radial shock wave therapy will be applied using the EMS Swiss DolorClast® device. Each session will consist of 3,000 impulses delivered at 20 Hz and 2 bar using a 40 mm applicator, targeting fibrotic tissue regions and periinguinal and peripopliteal lymph node areas. ESWT will be administered twice weekly for five sessions
Sham Extracorporeal Shock Wave Therapy (Sham ESWT)Device
Also called Sham Extracorporeal Shock Wave Therapy, Sham ESWT
Sham ESWT will be applied with identical positioning and session duration as the active ESWT group. Only non-energized impulses will be delivered, ensuring participant blinding. Sham ESWT will be administered twice weekly for five sessions.
| Study group | Role | What they receive |
|---|---|---|
| ESWT + CDT Maintenance | Experimental | Participants in this group receive active Extracorporeal Shock Wave Therapy (ESWT) applied to fibrotic tissue regions of the affected lower extremity and periinguinal and peripopliteal lymph node areas, in addition to standard CDT maintenance therapy. ESWT will be administered twice weekly for a total of five sessions. Receives: Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Sham ESWT + CDT Maintenance | Sham comparator | Participants in this group receive sham ESWT applied to the same anatomical regions using identical device positioning and application procedures, but with only non-energized impulses delivered. Standard CDT maintenance therapy will be continued throughout the study. Receives: Device: Sham Extracorporeal Shock Wave Therapy (Sham ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lower Extremity Limb Volume
Change in lower extremity limb volume calculated using the truncated cone formula. Volume will be estimated from circumferential measurements taken at 4 cm intervals from approximately 2 cm proximal to the medial malleolus to the inguinal region, with the patient in the supine position.
Measured: Baseline, immediately after treatment (week 3), and 1-month follow-up
Secondary outcomes (5)
Change in Lower Extremity Circumferential Measurements
Change in lower extremity circumferential measurements taken at 4 cm intervals from approximately 2 cm proximal to the medial malleolus to the inguinal region, with the patient in the supine position using a non-elastic tape measure. The difference between baseline and post-treatment values will be compared between groups.
Measured: Baseline, immediately after treatment (week 3) and 1-month follow-up
Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography
Change in skin and subcutaneous tissue thickness measured by B-mode linear ultrasonography at standardized anatomical sites on the affected lower extremity. Three measurements will be obtained at each site and averaged.
Measured: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Lymphedema-Specific Quality of Life (LYMQOL-Leg)
Lymphedema-specific quality of life will be assessed using the LYMQOL-Leg questionnaire, a patient-reported outcome measure consisting of 22 items evaluating function, body image, symptoms, and emotional well-being. Each item is scored from 1 to 4, and an overall quality of life score is rated separately on a scale from 0 to 10, with higher scores indicating better quality of life.
Measured: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Lower Extremity Functional Status (LEFS)
Lower extremity functional status will be assessed using the Lower Extremity Functional Scale (LEFS). The LEFS consists of 20 items, each scored from 0 to 4, yielding a total score ranging from 0 (extreme difficulty or inability to perform all activities) to 80 (no difficulty), with higher scores indicating better functional status.
Measured: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Pain Intensity Measured by Visual Analogue Scale (VAS)
Pain intensity will be assessed using a 10 cm Visual Analogue Scale (VAS). Scores range from 0 (no pain) to 10 (worst imaginable pain), with lower scores indicating less pain.
Measured: Baseline, immediately after treatment (week 3), and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Sep 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lymphedema, Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with lower extremity lymphedema will be randomly assigned to two parallel groups. The intervention group will receive active Extracorporeal Shock Wave Therapy (ESWT) in addition to standard Complex Decongestive Therapy (CDT) maintenance, while the control group will receive sham ESWT in addition to standard CDT maintenance. Both groups will continue compression garment use, skin care, and exercise throughout the study. ESWT will be administered twice weekly for five sessions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Utkan Karasu, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626645
- Sponsor's protocol ID
- GUFTR-LELymphedemaESWT-2026
- Status last verified
- Sep 2026
- First submitted
- 21 May 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cebicci MA, Sutbeyaz ST, Goksu SS, Hocaoglu S, Oguz A, Atilabey A. Extracorporeal Shock Wave Therapy for Breast Cancer-Related Lymphedema: A Pilot Study. Arch Phys Med Rehabil. 2016 Sep;97(9):1520-1525. doi: 10.1016/j.apmr.2016.02.019. Epub 2016 Mar 15.
PubMed 26987620Zhou JP, Lin YY, Zhu MF, Situ XX, Wang J. [Clinical effects of extracorporeal shock wave combined with complex decongestive therapy in the treatment of lower limb lymphedema after cervical cancer surgery]. Zhonghua Shao Shang Yu Chuang Mian Xiu Fu Za Zhi. 2025 Jun 20;41(6):543-551. doi: 10.3760/cma.j.cn501225-20250205-00051. Chinese.
PubMed 40588402Tsai YL, I TJ, Chuang YC, Cheng YY, Lee YC. Extracorporeal Shock Wave Therapy Combined with Complex Decongestive Therapy in Patients with Breast Cancer-Related Lymphedema: A Systemic Review and Meta-Analysis. J Clin Med. 2021 Dec 19;10(24):5970. doi: 10.3390/jcm10245970.
PubMed 34945266Lee KW, Kim SB, Lee JH, Kim YS. Effects of Extracorporeal Shockwave Therapy on Improvements in Lymphedema, Quality of Life, and Fibrous Tissue in Breast Cancer-Related Lymphedema. Ann Rehabil Med. 2020 Oct;44(5):386-392. doi: 10.5535/arm.19213. Epub 2020 Sep 28.
PubMed 32986941
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Lower Extremity Lymphedema: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07626645
- Acronym / sponsor ID
- GUFTR-LELymphedemaESWT-2026
- Conditions
- Lymphedema, Lower Limb, Extracorporeal Shock Wave Therapy, Edema Leg, Sham-controlled, Placebo Control Design
- Keywords
- Lower Extremity Lymphedema, Extracorporeal Shock Wave Therapy (ESWT), Complex Decongestive Therapy (CDT), Limb Volume, Ultrasonography, skin and subcutaneous tissue thickness, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life. The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the maintenance phase. This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) as an adjunct to standard CDT maintenance therapy in patients with lower extremity lymphedema. Participants will be randomly allocated to either an active ESWT group or a sham ESWT group, with both groups continuing standard CDT maintenance throughout the study. ESWT will be administered twice weekly for five sessions. Changes in limb volume, skin thickness and subcutaneous tissue thickness assessed by ultrasonography, pain, functional status, and quality of life will be evaluated at baseline, after treatment, and at one-month follow-up.
Detailed description
Lower extremity lymphedema results from impairment of the lymphatic system and is characterized by progressive tissue fibrosis, chronic limb swelling, recurrent infections, and reduced quality of life. Complex Decongestive Therapy (CDT), recommended by the International Society of Lymphology, remains the gold-standard treatment. Despite adherence to CDT, many patients continue to experience persistent symptoms and functional decline, underscoring the need for effective adjunctive interventions.
Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive modality that has shown potential benefits in reducing fibrosis and improving lymphatic function. While its efficacy has been reported in upper extremity lymphedema, evidence in lower extremity lymphedema remains limited.
This single-center, prospective, randomized, double-blind, placebo-controlled trial will be conducted at the Department of Physical Medicine and Rehabilitation, Gazi University Faculty of Medicine. Patients currently in CDT Phase 2 (maintenance phase) will be randomly assigned in a 1:1 ratio to receive either active ESWT or sham ESWT, using stratified randomization by lymphedema stage. All participants will continue standard maintenance therapy - compression garments, skin care, and exercise - throughout the study. ESWT will be applied to fibrotic tissue regions and periinguinal and peripopliteal lymph node areas using the EMS Swiss DolorClast® device, with 3,000 impulses per session at 20 Hz and 2 bar. The primary outcome is change in lower extremity circumferential measurements and limb volume. Secondary outcomes include skin and subcutaneous tissue thickness assessed by ultrasonography, pain intensity measured by the Visual Analogue Scale (VAS), lymphedema-specific quality of life evaluated by the LYMQOL-Leg, and functional status assessed by the Lower Extremity Functional Scale (LEFS). All outcomes will be assessed at baseline, immediately after treatment, and at one-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants with lower extremity lymphedema will be randomly assigned to two parallel groups. The intervention group will receive active Extracorporeal Shock Wave Therapy (ESWT) in addition to standard Complex Decongestive Therapy (CDT) maintenance, while the control group will receive sham ESWT in addition to standard CDT maintenance. Both groups will continue compression garment use, skin care, and exercise throughout the study. ESWT will be administered twice weekly for five sessions.
| Arm | Type | Receives |
|---|---|---|
| ESWT + CDT Maintenance | Experimental | Device: Extracorporeal Shock Wave Therapy (ESWT)Participants in this group receive active Extracorporeal Shock Wave Therapy (ESWT) applied to fibrotic tissue regions of the affected lower extremity and periinguinal and peripopliteal lymph node areas, in addition to standard CDT maintenance therapy. ESWT will be administered twice weekly for a total of five sessions. |
| Sham ESWT + CDT Maintenance | Sham comparator | Device: Sham Extracorporeal Shock Wave Therapy (Sham ESWT)Participants in this group receive sham ESWT applied to the same anatomical regions using identical device positioning and application procedures, but with only non-energized impulses delivered. Standard CDT maintenance therapy will be continued throughout the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 80 years
- Clinical diagnosis of lower extremity lymphedema established at least 6 months prior to enrollment
- Completion of at least one cycle of CDT Phase 1 (intensive decongestive phase) within the preceding six months
- Currently in CDT Phase 2 (maintenance phase) with active use of compression garments
- Ability and willingness to provide written informed consent
Key exclusion criteria (6 listed)
- Active chemotherapy or radiotherapy
- Active infection
- Lower extremity vascular diseases including deep vein thrombosis or arterial insufficiency
- Presence of a cardiac pacemaker
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shock Wave Therapy (ESWT)Also: Extracorporeal Shock Wave Therapy, ESWTRadial shock wave therapy will be applied using the EMS Swiss DolorClast® device. Each session will consist of 3,000 impulses delivered at 20 Hz and 2 bar using a 40 mm applicator, targeting fibrotic tissue regions and periinguinal and peripopliteal lymph node areas. ESWT will be administered twice weekly for five sessions | Device | ESWT + CDT Maintenance |
| Sham Extracorporeal Shock Wave Therapy (Sham ESWT)Also: Sham Extracorporeal Shock Wave Therapy, Sham ESWTSham ESWT will be applied with identical positioning and session duration as the active ESWT group. Only non-energized impulses will be delivered, ensuring participant blinding. Sham ESWT will be administered twice weekly for five sessions. | Device | Sham ESWT + CDT Maintenance |
Primary outcome
Change in Lower Extremity Limb Volume
Time frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in lower extremity limb volume calculated using the truncated cone formula. Volume will be estimated from circumferential measurements taken at 4 cm intervals from approximately 2 cm proximal to the medial malleolus to the inguinal region, with the patient in the supine position.
5 secondary outcomes
Change in Lower Extremity Circumferential Measurements
Time frame: Baseline, immediately after treatment (week 3) and 1-month follow-up
Change in Skin and Subcutaneous Tissue Thickness Assessed by Ultrasonography
Time frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Lymphedema-Specific Quality of Life (LYMQOL-Leg)
Time frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Lower Extremity Functional Status (LEFS)
Time frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Change in Pain Intensity Measured by Visual Analogue Scale (VAS)
Time frame: Baseline, immediately after treatment (week 3), and 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 26987620Cebicci MA, Sutbeyaz ST, Goksu SS, Hocaoglu S, Oguz A, Atilabey A. Extracorporeal Shock Wave Therapy for Breast Cancer-Related Lymphedema: A Pilot Study. Arch Phys Med Rehabil. 2016 Sep;97(9):1520-1525. doi: 10.1016/j.apmr.2016.02.019. Epub 2016 Mar 15.
- Background: PubMed 40588402Zhou JP, Lin YY, Zhu MF, Situ XX, Wang J. [Clinical effects of extracorporeal shock wave combined with complex decongestive therapy in the treatment of lower limb lymphedema after cervical cancer surgery]. Zhonghua Shao Shang Yu Chuang Mian Xiu Fu Za Zhi. 2025 Jun 20;41(6):543-551. doi: 10.3760/cma.j.cn501225-20250205-00051. Chinese.
- Background: PubMed 34945266Tsai YL, I TJ, Chuang YC, Cheng YY, Lee YC. Extracorporeal Shock Wave Therapy Combined with Complex Decongestive Therapy in Patients with Breast Cancer-Related Lymphedema: A Systemic Review and Meta-Analysis. J Clin Med. 2021 Dec 19;10(24):5970. doi: 10.3390/jcm10245970.
- Background: PubMed 32986941Lee KW, Kim SB, Lee JH, Kim YS. Effects of Extracorporeal Shockwave Therapy on Improvements in Lymphedema, Quality of Life, and Fibrous Tissue in Breast Cancer-Related Lymphedema. Ann Rehabil Med. 2020 Oct;44(5):386-392. doi: 10.5535/arm.19213. Epub 2020 Sep 28.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy (ESWT) in people with Lymphedema, Lower Limb and Extracorporeal Shock Wave Therapy, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayca Utkan Karasu, M.D (+905365759757 ext. +903122025219, ayca_utkan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lower Extremity Limb Volume (time frame: Baseline, immediately after treatment (week 3), and 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07626645, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.